Experimental combo targets Hard-to-Treat brain cancers
NCT ID NCT00268385
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This early-stage study tested the safety and best dose of vorinostat when given with the chemotherapy drug temozolomide in 83 adults with aggressive brain tumors called malignant gliomas. The goal was to see if adding vorinostat could make the tumor cells more sensitive to chemotherapy, potentially improving treatment. The study focused on finding the safest dose and monitoring side effects, not on curing the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
83 people
The number who actually took part.
- Started
-
Dec 2005
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with histologically proven intracranial malignant glioma will be eligible for this protocol; malignant gliomas include glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified); patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a malignant glioma is made * All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must have signed an authorization for the release of their protected health information; patients must be registered with the Adult Brain Tumor Consortium (ABTC) Central Office database prior to treatment with study drug * Life expectancy \> 8 weeks * Karnofsky performance status of \>= 60 * White blood cell (WBC) \>= 3,000/mm\^3 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL; eligibility level for hemoglobin may be reached by transfusion * Serum glutamic oxaloacetic transaminase (SGOT) \< 2 times upper limit of normal (ULN) * Bilirubin \< 2 times ULN * If liver function tests are above the institutional upper limit of normal but \< 2 times institutional upper limit of normal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient * Creatinine \< 1.5 mg/dL * A scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days; if the steroid dose is increased between the date of imaging and registration a new baseline magnetic resonance (MR)/computed tomography (CT) is required; the same type of scan, i.e., magnetic resonance imaging (MRI) or CT must be used throughout the period of protocol treatment for tumor measurement * Patients must have an interval of greater than or equal to 3 weeks (21) days from the completion of radiation therapy to study entry * Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 7 days prior to registration; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of participation in the study * Patients must be willing to participate in the pharmacokinetic studies * ELIGIBILITY CRITERIA SPECIFIC FOR PATIENTS IN PART I OF THE STUDY * Patients with either stable disease after radiation therapy or with progression are eligible (except if they have progressed on temozolomide; patients who have received prior treatment with temozolomide and have stable disease are eligible * Patients with recurrent disease may have had treatment for any number of prior relapses; relapse is defined as progression following initial therapy (i.e. radiation +/- chemo if that was used as initial therapy) * Patients must have recovered from the toxic effects of prior therapy: 28 days from any investigational agent, 28 days from prior cytotoxic therapy except 23 days from last dose of temozolomide for patients taking the standard 5 days every 28 day regimen of temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration, and 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count); any questions related to the definition of non-cytotoxic agents should be directed to the study chair * Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: * They have recovered from the effects of surgery * Residual disease following resection is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration; if the 96-hour scan is more than 14 days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days * Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) or thallium scanning, MR spectroscopy or surgical documentation of disease * ELIGIBILITY CRITERIA SPECIFIC FOR PATIENTS IN PART II OF THE STUDY * Only patients with stable disease after radiation therapy are eligible for part 2 of the study; patients with recurrent disease are ineligible * The only prior therapy permitted for patients in part 2 of the study is concomitant temozolomide with radiation therapy or radiation therapy alone; patients that are stable on adjuvant temozolomide may also participate * Patients with recurrent disease and prior chemotherapies (except concurrent or adjuvant temozolomide) will not be included in this part of the study Exclusion Criteria: * Patients who have progressed on temozolomide are ineligible * Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible * Patients must not have active infection or serious intercurrent medical illness * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with vorinostat (SAHA); potential risks may also apply to temozolomide * Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism * Patients who are known to be human immunodeficiency virus (HIV) positive and are receiving combination antiretroviral therapy are ineligible * Patients may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA) or other agents used in study * Patients should not have taken valproic acid (another histone deacetylase inhibitor) for at least 2 weeks prior to enrollment
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adult anaplastic astrocytoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
-
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
-
Henry Ford Hospital
Detroit, Michigan, 48202, United States
-
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Moffitt Cancer Center
Tampa, Florida, 33612, United States
-
National Cancer Institute Neuro-Oncology Branch
Bethesda, Maryland, 20892, United States
-
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
-
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
-
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
-
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
-
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
-
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
-
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
-
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug targets Sugar-Coated proteins on cancer cells
- Off-the-Shelf immune cells target solid tumors
- Can a RAGE inhibitor tame brain swelling after tumor surgery?
- Can new PET scans guide brain tumor catheters more precisely?
- Could a parasite drug fight childhood brain tumors?
- Can mapping the Blood-Brain barrier in brain tumors unlock new clues?